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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE

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 Class 2 Device Recall MEDLINEsee related information
Date Initiated by FirmSeptember 09, 2026
Date PostedOctober 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0269-2027
Recall Event ID 99960
Product Classification Drape, surgical, exempt - Product Code PUI
ProductMEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101
Code Information UDI/DI 10080196913589 (each) 40080196913580 (case), Lot numbers: 31124090032F, 31125080028F, 31126050023F, 31126060021F.
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
866-359-1704
Manufacturer Reason
for Recall		Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
FDA Determined
Cause 2		Under Investigation by firm
ActionMEDLINE issued a MEDICAL DEVICE CORRECTION notice to its consignees on 9/9/2023 via US mail and email. The notice explained the issue and circumstances under which it can occur, hazard involved, and requested the user follow specific patient skin preparation, product application considerations, and removal recommendations. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce4765 units
DistributionWorldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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